Radiology AI Directory

FDA-cleared profile

vascuCAP

Elucid Bioimaging Inc.

vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and measurements for physician review.

Cardiac imagingDetection and CADeQuantification and segmentation
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and measurements for physician review.
FDA source Exact FDA submission Checked 2026-09-03
Intended users
Qualified imaging professionals and physicians trained for the represented anatomy and workflow.
FDA source Exact FDA submission Checked 2026-09-03
Care setting and population
Hospital or outpatient imaging analysis and reporting environments.
FDA source Exact FDA submission Checked 2026-09-03
Workflow role
Medical-image processing, measurement, quantification, visualization, and reporting support.
FDA source Exact FDA submission Checked 2026-09-03
Required input
Supported DICOM images and release-specific user inputs.
FDA source Exact FDA submission Checked 2026-09-03
Output and human action
Measurements, segmentations, visualizations, calculations, and reports for professional review.
FDA source Exact FDA submission Checked 2026-09-03
Limitations
Measurements and maps are adjunctive and are not intended to make a diagnosis or clinical recommendation. Verify contrast timing, arterial coverage, reconstruction, manual edits, and the exact validated vessel set locally.
FDA source Exact FDA submission Checked 2026-09-03

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K183012
FDA source Exact FDA submission Checked 2026-08-31
Modality
CT/CTA
FDA source Exact FDA submission Checked 2026-09-03
Anatomy
Heart/Cardiovascular
FDA source Exact FDA submission Checked 2026-09-03
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2018-12-21
FDA source Exact FDA submission Checked 2026-08-31
FDA status
FDA-cleared
FDA source Exact FDA submission Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
DICOM import and output to PACS, reporting, or downstream systems; validate identifiers, series selection, measurements, units, geometry, routing, and round trips.
FDA source Exact FDA submission Checked 2026-09-03
Deployment and data flow
Software on a workstation, server, or supported virtual environment with release-specific licenses.
FDA source Exact FDA submission Checked 2026-09-03
Security and privacy
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified imaging professionals and physicians trained for the represented anatomy and workflow should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
FDA source Exact FDA submission Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Measurements and maps are adjunctive and are not intended to make a diagnosis or clinical recommendation. Verify contrast timing, arterial coverage, reconstruction, manual edits, and the exact validated vessel set locally.
FDA source Exact FDA submission Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K183012 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

DICOM import and output to PACS, reporting, or downstream systems; validate identifiers, series selection, measurements, units, geometry, routing, and round trips.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. The capability is derived from the exact FDA workflow and still requires local acceptance testing.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Measurements and maps are adjunctive and are not intended to make a diagnosis or clinical recommendation. Verify contrast timing, arterial coverage, reconstruction, manual edits, and the exact validated vessel set locally.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Measurements and maps are adjunctive and are not intended to make a diagnosis or clinical recommendation. Verify contrast timing, arterial coverage, reconstruction, manual edits, and the exact validated vessel set locally.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. The capability is derived from the exact FDA workflow and still requires local acceptance testing.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
K183012 reports software, measurement, visualization, and clinical testing for arterial CT analysis. Measurements are not intended to establish a diagnosis or clinical recommendation and complement standard of care; the public FDA summary does not provide a reliable single sensitivity or specificity value.
FDA source Exact FDA submission Checked 2026-09-03
Reported sensitivity
Not applicable
Not applicable Not applicable Checked 2026-09-03

Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
Not applicable Not applicable Checked 2026-09-03

Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K183012 FDA performance package for vascuCAP

Manufacturer analytical, software, measurement, visualization, and clinical validation · Contrast multidetector CT examinations of arterial vessels for atherosclerosis stratification

exact submission · Tested version: vascuCAP · Sponsor or vendor study

K183012

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

Intra- and inter-reader reproducibility in quantitative coronary plaque analysis on coronary computed tomography angiography.

Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related CT/CTA workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

38688396

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

Treatment of Psoriasis With Biologic Therapy Is Associated With Improvement of Coronary Artery Plaque Lipid-Rich Necrotic Core: Results From a Prospective, Observational Study.

Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related CT/CTA workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

32927971

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

A Propensity-Matched Comparison of Ischemic Brain Lesions on Postprocedural MRI in Endovascular versus Open Carotid Artery Reconstruction.

Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related CT/CTA workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

37367422

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

Non-invasive Computer-Aided Phenotyping of Vasculopathy

ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related CT/CTA workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

NCT02143102

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

Carotid Risk Prediction (CRISP) Consortium

ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related CT/CTA workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

NCT04448353

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
Public source Not applicable Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K183012 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
25Fields reviewed
10Source classes checked
5Unreviewed PubMed leads
3Unreviewed trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 5 PubMed and 3 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-03.

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